NCT01365039已完成不适用
A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Slit Lamp Findings > Grade 2
研究概览
简要总结
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
- •Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
- •Subjects must be free of any anterior segment disorders.
- •Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
排除标准
- •Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who are allergic to any component in the study care products.
结局指标
主要结局
Slit Lamp Findings > Grade 2
时间窗: 4 visits over 3 months
Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
High Contrast, Distance logMAR Visual Acuity (VA)
时间窗: 4 visits over 3 months
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact LensMyopiaNCT02676258Visco Vision Inc.60
已完成
不适用
Performance Evaluation of a New Daily Disposable Silicone Hydrogel LensMyopiaNCT01371552CIBA VISION119
已完成
不适用
A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact LensContact Lens WearNCT04158466Bausch & Lomb Incorporated252
终止
不适用
Silicone Hydrogel Contact Lenses on Low Astigmatism in JapanMyopiaAstigmatismRefractive ErrorNCT00639353Johnson & Johnson Vision Care, Inc.102
已完成
不适用
Clinical Evaluation of a Silicone Hydrogel LensMyopiaNCT01016132CIBA VISION152